By Deena Beasley and Carl O’Donnell
(Reuters) -A pill developed by US drugmaker Merck, could reduce the chance of dying or being hospitalized by half COVID-19, with experts considering it a possible breakthrough in the treatment of the virus.
If approved, molnupiravir, designed to introduce errors in the genetic code of the virus, is the first oral antiviral medication for COVID-19.
Merck and his partner Ridgeback Biotherapeutics plan to seek US emergency clearance for the pill as soon as possible and to make regulatory applications worldwide.
‘It will change the dialogue on how to manage COVID-19, “Merck CEO Robert Davis told Reuters.
Current treatment options include Gilead Sciences Inc.’s antiviral inhibitor and generic steroid dexamethasone, although both are usually given only once a patient has been admitted to hospital.
“An oral antiviral drug that can affect the risk of hospitalization to such an extent can change the game,” said Amesh Adalja, a senior scientist at the Johns Hopkins Center for Health Safety.
Existing treatments are “cumbersome and logistically challenging to administer. A simple oral pill would be the opposite of that, ”Adalja added.
Due to the positive results, which increased Merck’s shares in early trading in New York by more than 9%, the phase 3 trial is stopped early on the recommendation of external monitors.
Shares of COVID-19 vaccine manufacturers Pfizer and Moderna have fallen by almost 3% and 10% respectively, says Michael Yee, a biotechnology analyst at Jefferies, said investors believe ‘people will be less scared’ COVID and less likely to get vaccines if there is a simple pill what can treat COVID“.
Pfizer and Swiss pharmaceutical group Roche pursue easy-to-administer antiviral drugs pill https://www.reuters.com/business/healthcare-pharmaceuticals/covid-19-pill-developers-aim-top-merck-pfizer-efforts-2021-09-28 for COVID-19, but so far only intracellular cocktails to be administered intravenously are approved for patients who are not hospitalized.
A planned interim analysis of 775 patients in Merck’s study looks at hospitalizations or deaths. It found that 7.3% of those who received molnupiravir were hospitalized and that no one died 29 days after treatment, compared with 14.1% of placebo patients. There were eight deaths among placebo patients.
‘Antiviral treatments that can be taken at home to help people’ COVID“19 out of the hospital is extremely important,” Ridgeback CEO Wendy Holman said in a statement.
“WORKING WITH ALACRITY”
Scientists welcome the possible new treatment to prevent serious diseases of the virus, which has killed nearly 5 million people worldwide.
“The availability of a well-tolerated, effective oral antiviral drug will be particularly helpful in supplementing vaccination as a way to reduce the number of patients in need of hospital care,” said Penny Ward, visiting professor of pharmaceutical medicine at King’s College. in London, said.
In the trial, which enrolled patients around the world, molnupiravir was taken every 12 hours for five days.
The study enrolled patients with light-to-moderate laboratory confirmation COVID-19, who had no symptoms for more than five days. All patients have at least one risk factor associated with a poor disease outcome, such as obesity or older age.
Merck said that viral sequences done so far show that molnupiravir is effective against all variants https://www.reuters.com/business/healthcare-pharmaceuticals/merck-says-research-shows-its-covid-19-pill-work-against-variants-2021-09-29 of the coronavirus, including highly transmissible Delta.
The number of side effects is said to be the same for patients with molnupiravir and placebo, but no details were given.
Merck said data show that molnupiravir cannot cause genetic changes in human cells, but men enrolled in the trials must refrain from heterosexual intercourse or agree to use contraception. Women of childbearing potential cannot become pregnant and should also use birth control.
Merck said it will plan 10 million treatments by the end of 2021, and more next year.
The company has a U.S. government contract to supply 1.7 million molnupiravir courses at a price of $ 700 per course.
Davis said Merck has similar agreements with other governments and is in talks with more. Merck said he plans a dedicated pricing approach based on the country’s revenue criteria.
Merck has also agreed to license the drug to several generic drugmakers in India, which could deliver the treatment to low- and middle-income countries.
Molnupiravir is also being studied in a phase 3 trial for the prevention of coronavirus infection in people exposed to the virus.
Merck officials said it was unclear how long the FDA review would take, although Dean Li, head of Merck’s research labs, said: “They are going to try to work with sharpness on this.”
(Reported by Deena Beasley; Additional Reporting by Josephine Mason, Edited by Lincoln Feast, Kirsten Donovan and Alexander Smith)